FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ophthalmic ×
5,110 results
3001–3024 of 5,110
Search insights Median review: 83d Cleared: 100% Top manufacturer: CooperVision, Inc. Lead specialty: Ophthalmic
Cleared Jan 25, 1994
PHACOFRAGMENTOR TIP
K933627 · HQC
M. Imonti and Associates Inc.,
Ophthalmic · 182d
Cleared Jan 25, 1994
STORZ FIBEROPTIC REVERSE CUTTING KNIFE
K933984 · HQE
Storz Instrument Co.
Ophthalmic · 162d
Cleared Jan 25, 1994
SPECTACLE FRAMES AND SUNGLASSES
K934187 · HQZ
Wah Ming Optical Mfy. , Ltd.
Ophthalmic · 152d
Cleared Jan 25, 1994
OPTIKOS SHAMI, INC. SUNGLASSES
K934197 · HQY
Optikos Shami, Inc.
Ophthalmic · 152d
Cleared Jan 25, 1994
COOL KIDS MIRROR SHADES
K934402 · HQY
Ja-Ru, Inc.
Ophthalmic · 138d
Cleared Jan 25, 1994
SURGITEL
K934494 · HOH
General Scientific Corp.
Ophthalmic · 132d
Cleared Jan 25, 1994
ELECTRIC I/V POLE OR EIVP2
K935003 · KYG
Optical Micro Systems, Inc.
Ophthalmic · 98d
Cleared Jan 25, 1994
SPECTACLE FRAMES
K935107 · HQZ
Mr I'S Optical Boutique
Ophthalmic · 95d
Cleared Jan 25, 1994
TALE SPIN SUNSHADES
K935231 · HQY
Equity Marketing, Inc.
Ophthalmic · 85d
Cleared Jan 25, 1994
SPECTACLE FRAME/EYEGLASS FRAME
K935558 · HQZ
Modern Optical , Ltd.
Ophthalmic · 69d
Cleared Jan 06, 1994
OPHTHALMIC TRIAL LENSES
K930195 · HPC
Optimark Accessories and Instruments
Ophthalmic · 357d
Cleared Jan 06, 1994
VISUAL SCENE SUNGLASSES
K932469 · HQY
Vsi Intl., Inc.
Ophthalmic · 230d
Cleared Jan 06, 1994
PRO-PHACO HANDPIECE
K933503 · HQC
M. Imonti and Associates Inc.,
Ophthalmic · 171d
Cleared Jan 06, 1994
FINE OPTICS SUNGLASSES
K933938 · HQY
Fine Optics, Inc.
Ophthalmic · 147d
Cleared Jan 06, 1994
SUNGLASSES
K934020 · HQY
Sun Probe Enterprise Co., Ltd.
Ophthalmic · 142d
Cleared Jan 06, 1994
BIKER MICE SUNGLASSES
K935165 · HQY
Ja-Ru, Inc.
Ophthalmic · 69d
Cleared Jan 06, 1994
SUNGLASSES
K935541 · HQY
Seven Pyramid Ent Co., Ltd.
Ophthalmic · 51d
Cleared Jan 03, 1994
FLOATS SUNGLASSES
K932151 · HQY
Floats, Inc.
Ophthalmic · 244d
Cleared Jan 03, 1994
SPECTACLE FRAMES
K932439 · HQZ
Styl-Rite Optics, Inc.
Ophthalmic · 229d
Cleared Dec 27, 1993
VISI-SPEAR EYE SPONGE
K933872 · HOZ
Visitec Co.
Ophthalmic · 143d
Cleared Dec 21, 1993
RUSSELL & HANCOCK 524 AND 422 SUNGLASSES
K933323 · HQY
Russell & Hancock, Ltd.
Ophthalmic · 167d
Cleared Dec 21, 1993
CONTACT LENSES
K934859 · HPC
Arno Intl., Inc.
Ophthalmic · 70d
Cleared Dec 16, 1993
BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE
K934084 · HMJ
Bioenterics Corp.
Ophthalmic · 118d
Cleared Dec 14, 1993
BARE-FIBER ENDOILLUMINATOR
K933208 · HQE
Surgical Technologies, Inc.
Ophthalmic · 166d